ORIGINAL RESEARCH
Transpl. Int.
Association Between Cytomegalovirus Viremia Clearance and Post-Solid Organ Transplant Mortality in Patients With Refractory Cytomegalovirus Infection: SOLSTICE Post Hoc Analysis
Nassim KAMAR 1
Robin K Avery 2
Tien Bo 3
Joan Gu 3
Deepali Kumar 4
Oliver Witzke 5
1. Centre Hospitalier Universitaire de Toulouse, Toulouse, France
2. The Johns Hopkins University School of Medicine, Baltimore, United States
3. Takeda Development Center Americas Inc, Cambridge, United States
4. Ajmera Transplant Centre, University Health Network, Toronto, Canada
5. Department of Infectious Diseases, West German Centre of Infectious Diseases, University Medicine Essen, University Duisburg-Essen, Essen, Germany
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Abstract
Cytomegalovirus (CMV) infection following solid organ transplant (SOT) is associated with increased mortality risk. In the phase 3 SOLSTICE study (NCT02931539), more transplant recipients achieved CMV clearance after 8 weeks with maribavir than investigator-assigned therapy (IAT). In SOLSTICE, SOT recipients with refractory CMV infection were randomized 2:1 to receive maribavir or IAT for 8 weeks. This post hoc analysis assessed the impact of CMV clearance at Week 8 on mortality at Week 20. Patients who achieved CMV clearance at Week 8 were categorized as responders, and patients without CMV clearance, or who received maribavir rescue or alternative treatment, were categorized as nonresponders. All-cause mortality was assessed at Week 20 for responders and nonresponders using the Kaplan-Meier method with log-rank test. The analysis included 211 SOT recipients: 97 responders and 114 nonresponders. Week 20 all-cause mortality was significantly higher in nonresponders than responders (p = 0.0024). No deaths were reported in the responder group, and 10 deaths were reported in the nonresponder group (3 receiving IAT, 7 receiving maribavir). Median (range) time from treatment start to death was 30.5 (3–123) days. This analysis is consistent with other studies showing an increased risk of mortality with post-SOT CMV infection.
Summary
Keywords
SOT (solid organ transplant), survival, anti-CMV therapy, maribavir, antiviral
Received
28 July 2025
Accepted
10 November 2025
Copyright
© 2025 KAMAR, Avery, Bo, Gu, Kumar and Witzke. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Nassim KAMAR, kamar.n@chu-toulouse.fr
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